Home Applications 020726 Application 020726
Type NDA
Sponsor NOVARTIS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FEMARA LETROZOLE TABLET;ORAL 2.5MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020726-001 FEMARA LETROZOLE 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020726-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Femara LETROZOLE Novartis Pharmaceuticals Corporation 82b77d74-085f-45ac-a7dd-1f5c038bf406 2026-06-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 020726 application number: NDA020726 ndc (product): 0078-0249
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0249 Femara letrozole Novartis Pharmaceuticals Corporation NDA Current 0078-0249 Femara letrozole Novartis Pharmaceuticals Corporation NDA Current 0078-0249 Femara letrozole Novartis Pharmaceuticals Corporation NDA Current 0078-0249 Femara letrozole Novartis Pharmaceuticals Corporation NDA Current 0078-0249 Femara letrozole Novartis Pharmaceuticals Corporation NDA Current 0078-0249 Femara letrozole Novartis Pharmaceuticals Corporation NDA Current